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GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion pushed from Dec 30, 2026 to Dec 30, 2027v7 Show 4 more changesShow less
    • Enrollment reduced: 12 → 6 participants
    • Study completion pushed from Feb 28, 2027 to Feb 28, 2028
    • Eligibility criteria revised
    • Study description shortened, about 15 words
  2. Start date changed from estimate of Oct 2025 to Nov 19, 2025v6
  3. Re-verified, no change to tracked fieldsv5
  4. Eligibility criteria expanded, about 22 wordsv4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date: Jun 30, 2025 to Oct 2025
    • Secondary endpoints revised (12)
    • Site details revised
    • Study description expanded, about 1 word
  6. Start date: Apr 30, 2025 to Jun 30, 2025v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an investigator initiated, single center, open label, non-randomized, exploratory clinical study. The purpose is to assess the safety and preliminary efficacy of gene therapy GVB-2001 (ScAAV2-dnRhoA) delivered via intracameral injection to the anterior segment of the eye for the treatment of subjects with primary open-angle glaucoma. At least 6 primary open angle glaucoma (POAG) patients with high intraocular pressure (IOP) will be divided into two experimental groups. The first subject was given low-dose treatment, and the follow-up subjects were determined by the Safety Review Committee (SRC). Each experimental group was given low-dose and high-dose drug treatment respectively, and low-dose or high-dose treatment was given. The optimal dose will be selected based on the trial results for future development of GVB-2001. Safety Review Committee, SRC will be set up for safety assessment of the study. The study subjects included will be 18 to 75 years of age (inclusion) and are diagnosed with primary open-angle glaucoma (POAG) for 1 year or more. Only participants who provide informed consent prior to all screening procedures will be eligible for enrollment into the trial.
Trial Details
NCT Number NCT06921317
Lead Sponsor IVIEW Therapeutics Inc.
Collaborators: The First Affiliated Hospital of Soochow University
Conditions
(from sponsor)		 Primary Open-Angle Glaucoma (POAG)
Related terms Glaucoma, Glaucoma, Open-Angle, Night Blindness, Congenital Stationary, Autosomal Dominant 1
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov